This invention generally relates to the field of multi-layered materials, including those that closely mimic a property of human or animal tissue or components of the body known as synthetic tissue phantoms. Synthetic tissue phantoms can be used for evaluating medical devices for research, training, and user feedback purposes. The invention also relates to the field of materials that can be used to simulate specific tissues such as fat tissue or skin tissue.
Synthetic tissue phantoms include tissue-mimicking materials and are used as tools for the assessment and verification of performance standards in daily clinical practices. Tissue-mimicking materials should exhibit the same properties as those of the actual human or animal tissue.
An example of a synthetic tissue phantom that includes tissue-mimicking materials is disclosed in U.S. Pat. No. 4,227,367. In one embodiment, the tissue-mimicking material is prepared from a mixture of gelatin, water, n-propanol, and graphite powder. In another embodiment, the tissue-mimicking material includes a mixture of gelatin and oil.
U.S. Pat. No. 4,481,001 discloses a skin model for practicing intradermal injections of fluids. The skin model includes a subcutaneous-simulating layer, a dermis-simulating layer, and an epidermis-simulating layer.
Another example is an artificial breast phantom disclosed in U.S. Pat. No. 7,419,376. In one embodiment, the tissue-mimicking material includes a two-component silicone gel having varying elastic properties and Young's modulus from 3 kPa to 600 kPa. See also U.S. Pat. Nos. 8,613,621, 8,708,707, 8,915,742 and 8,968,003.
There is always room for improvement in synthetic tissue phantoms that mimic at least some aspects human or animal tissue for use in research and training of professionals.
There is also a desire for synthetic tissue phantoms for use in training clinical practitioners in inserting medical devices, between layers such as the skin and muscle.
It is also desirable to provide improvements in synthetic tissue phantoms such as phantoms that can be made more simply, efficiently, and/or effectively, but nonetheless, provide the degree of realism necessary to satisfy their objective. In particular, it is desirable to provide fatty materials that can be used to produce fat layers, which provide sensory feedback to the user and are similar to the fat layer of a human or animal when used as described. And improved skin material and layer are also contemplated.
In some embodiments, the invention can address at least one of these desires—it need not address them all.